hydroxyzine pamoate

Product NDC: 14539-675
11-digit product format: 145390675
Labeler code: 14539
Product ID: 14539-675_843627c2-146c-4715-b5b5-8c5c80a8f615
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA201507
Marketing category: ANDA
Marketing start: 2013-06-03
Substance: HYDROXYZINE PAMOATE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201507-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03
A201507-002	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201507-001	AB
A201507-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201507-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201507-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201507-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201507-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201507-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201507-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201507-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201507-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201507-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201507-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201507-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201507-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201507-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201507-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201507-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201507-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201507-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201507-002	BX	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: hydroxyzine pamoate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE PAMOATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M20215MUFR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995253	Internal RxNorm lookup
995278	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
734d32c8-38d3-430f-a2b3-539e03a3687a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57311cfb-679a-da1a-b70c-8757f7fc431a	Product name	4	20250516
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
aa1826f4-97c1-4705-bdf0-3bc7d234e618	Product name	2	20190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41	Product name	1	20151110
3ca5f78b-43dc-30fe-8014-55b922af52b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14539-675-01	hydroxyzine pamoate	100 in 1 CONTAINER	CAPSULE	100		6
14539-675-05	hydroxyzine pamoate	500 in 1 CONTAINER	CAPSULE	500		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
14539-675-01	EA - Each	14539-675	6f8d8e89-3e6a-4722-bc95-f280a0dac9f1	1	2019-07-02
14539-675-05	EA - Each	14539-675	a8fdaf47-c495-43e6-b285-16efa9d38271	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14539-675	HYDROXYZINE PAMOATE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240203_734d32c8-38d3-430f-a2b3-539e03a3687a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Cardinal Health 107, LLC	6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	5020c699-6fc5-b166-e063-6294a90a5881	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals Inc.	b903f7e1-250d-46d8-a1ec-3f1dabc597f1	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	127617c2-9775-3859-e063-6394a90a77cd	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	db8987d6-9814-50f6-e053-2a95a90a82a9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Chartwell RX, LLC	abe7280a-1f6a-404b-9874-7710121e2090	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Major Pharmaceuticals	f28f2a1b-8d65-4646-bd99-6e77617f9e1f	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	7996dfa3-7f34-4d20-acaa-7f6fc021fc80	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	c0f7f48d-e39c-4981-9c0e-5c2eccaba424	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Golden State Medical Supply, Inc.	240fd428-15af-e7d0-e063-6394a90acbc5	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	734d32c8-38d3-430f-a2b3-539e03a3687a	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507 ndc (product): 14539-675
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals, Inc.	2a66117a-fcd4-4094-927c-3a7699ef9660	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	74bf62c3-b444-46dc-aab6-af74b101a68a	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	308cd178-a9d2-3132-e063-6394a90a7357	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	8c395a13-9da3-7b77-e053-2995a90a1916	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	a31271f0-ac60-4fda-b1f5-ddf7241c8a0e	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8cb94f1d-1e45-531a-e053-2a95a90a1ba0	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	dde576e9-fb6b-40d2-a81f-ebb8656c4c9c	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	1302c511-eb25-5818-e063-6394a90a9225	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	78005ad7-290c-4716-937f-f0ec82f4e607	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M20215MUFR	HYDROXYZINE PAMOATE	10246-75-0	HYDROXYZINE PAMOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	74bf62c3-b444-46dc-aab6-af74b101a68a	10
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	74bf62c3-b444-46dc-aab6-af74b101a68a	10
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	74bf62c3-b444-46dc-aab6-af74b101a68a	10
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	734d32c8-38d3-430f-a2b3-539e03a3687a	6
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	dde576e9-fb6b-40d2-a81f-ebb8656c4c9c	6
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	734d32c8-38d3-430f-a2b3-539e03a3687a	6
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	734d32c8-38d3-430f-a2b3-539e03a3687a	6
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	dde576e9-fb6b-40d2-a81f-ebb8656c4c9c	6
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	734d32c8-38d3-430f-a2b3-539e03a3687a	6
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	734d32c8-38d3-430f-a2b3-539e03a3687a	6
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	dde576e9-fb6b-40d2-a81f-ebb8656c4c9c	6
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	127617c2-9775-3859-e063-6394a90a77cd	3
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	127617c2-9775-3859-e063-6394a90a77cd	3
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	127617c2-9775-3859-e063-6394a90a77cd	3
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	240fd428-15af-e7d0-e063-6394a90acbc5	2
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	240fd428-15af-e7d0-e063-6394a90acbc5	2
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	c0f7f48d-e39c-4981-9c0e-5c2eccaba424	2
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	b903f7e1-250d-46d8-a1ec-3f1dabc597f1	2
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	240fd428-15af-e7d0-e063-6394a90acbc5	2
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	240fd428-15af-e7d0-e063-6394a90acbc5	2
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	c0f7f48d-e39c-4981-9c0e-5c2eccaba424	2
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	b903f7e1-250d-46d8-a1ec-3f1dabc597f1	2
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	b903f7e1-250d-46d8-a1ec-3f1dabc597f1	2
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	c0f7f48d-e39c-4981-9c0e-5c2eccaba424	2
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	240fd428-15af-e7d0-e063-6394a90acbc5	2
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	1302c511-eb25-5818-e063-6394a90a9225	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	1302c511-eb25-5818-e063-6394a90a9225	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	1302c511-eb25-5818-e063-6394a90a9225	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
14539-675-01	14539067501	100 CAPSULE in 1 CONTAINER (14539-675-01)	100 capsule	2019-04-23	0000-00-00	No	No	Current
14539-675-05	14539067505	500 CAPSULE in 1 CONTAINER (14539-675-05)	500 capsule	2019-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx only	Preferred Pharmaceuticals Inc.	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
Rx only	Northwind Health Company, LLC	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	3
Rx only	REMEDYREPACK INC.	2025-09-11	HUMAN PRESCRIPTION DRUG LABEL	2
Hydroxyzine Pamoate Capsules Rx only	Golden State Medical Supply, Inc.	2025-08-06	HUMAN PRESCRIPTION DRUG LABEL	2
Rx only	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	6
Rx only	A-S Medication Solutions	2025-04-28	HUMAN PRESCRIPTION DRUG LABEL	10
Rx only	REMEDYREPACK INC.	2025-04-21	HUMAN PRESCRIPTION DRUG LABEL	12
Rx only	Bryant Ranch Prepack	2024-05-17	HUMAN PRESCRIPTION DRUG LABEL	6
Rx only	NuCare Pharmaceuticals,Inc.	2024-03-06	HUMAN PRESCRIPTION DRUG LABEL	1
Rx only	REMEDYREPACK INC.	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	7
Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2021-03-25	HUMAN PRESCRIPTION DRUG LABEL	3